The Effect of Valacyclovir on the Detection of HIV From Genital Herpes Lesions in HIV-Infected Patients

This study has been completed.

Sponsor:

Glaxo Wellcome

ClinicalTrials.gov Identifier:

NCT00002404

First Posted: August 31, 2001

Last Update Posted: January 29, 2008

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Following evaluation for 2 consecutive episodes of genital herpes in this double-blind, crossover study, 30 HIV-1 positive patients are randomized to receive either valacyclovir or placebo.

All patients are treated for 10 days.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

Patients must have:

Serologically documented HSV-2 and HIV-1 infection.

History of recurrent genital herpes that presents at least 3 recurrences within the 12 months prior to the start of study.

No contraindications to valacyclovir.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Hepatic impairment.

Impaired renal function (creatinine above 2 mg/dl).

Malabsorption syndrome or other gastrointestinal dysfunction.

Any other condition that in the investigator's opinion would interfere with study procedures or successful completion of protocol.

Patients with the following prior conditions are excluded:

History of hypersensitivity to acyclovir or valacyclovir.

Prior Medication:

Excluded:

Participation in any investigational drug trial within 1 month prior to entry on study.